About FDA


On April 16, 2010, the U. S. Food and Drug Administration (FDA) approved erlotinib (Tarceva) tablets for maintenance treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. This approval is erlotinib’s second indication in locally advanced or metastatic NSCLC. Erlotinib was originally approved in November, 2004 for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.

The efficacy and safety of erlotinib as maintenance treatment were demonstrated in a randomized, double-blind, placebo-controlled, multinational trial. A total of 889 patients with locally advanced or metastatic NSCLC whose disease did not progress during first-line platinum-based chemotherapy were randomized (1:1) to receive either erlotinib (150 mg) or placebo orally once daily until disease progression or unacceptable toxicity. The trial’s primary objective was to determine if the administration of erlotinib after standard platinum-based chemotherapy resulted in improved progression-free survival (PFS) when compared to placebo in either all patients or in patients with EGFR immunohistochemistry (IHC) positive tumors. Overall survival (OS) was a secondary endpoint in the trial but was designated as the regulatory endpoint for approval of this indication.

Patient demographics and disease characteristics were balanced between the two groups. Approximately 70% of patients’ tumors were EGFR positive. The hazard ratio (HR) for PFS was 0.71 (95% CI: 0.62, 0.82, p<0.0001). The HR for OS was 0.81 (95% CI: 0.70, 0.95, p=0.0088). The PFS and OS hazard ratios in patients with EGFR IHC-positive tumors were 0.69 (95% CI: 0.58, 0.82) and 0.77 (95% CI: 0.64, 0.93), respectively. The PFS and OS hazard ratios in patients with IHC-negative tumors were 0.77 (95% CI: 0.51, 1.14) and 0.91 (95% CI: 0.59, 1.38), respectively.

Following disease progression, a greater proportion of patients in the placebo group (57%) received second-line treatment for NSCLC compared to the erlotinib group (47%). Of the 259 patients in the placebo group who received second-line treatment, thirty-seven (14%) received either erlotinib or gefitinib at first progression, 31% received docetaxel, and 14% received pemetrexed. In total, 59% of patients in the placebo group who received treatment at the time of tumor progression received FDA-approved second-line NSCLC drugs.

The safety results for patients treated with erlotinib were consistent with the known safety profile previously described in product labeling. The most common (>20%) adverse reactions in patients receiving erlotinib were rash-like events and diarrhea.

Full prescribing information, including clinical trial information, safety, dosing, drug-drug interactions and contraindications is available at 



Page Last Updated: 11/27/2015
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